QSIT 1 -- Beginning the Inspection
This is the first in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. Topics in this course include: Scope, Other Considerations, Sampling, and Reporting. After completing this course, learners will be able to recognize the purpose of QSIT during investigations of medical device manufacturers
After this course learners will be able to recognize the origin and scope of qsit. recognize the basic concepts associated with how to sample records for review during an inspection conducted according to qsit and how to report your findings (if necessary) in an establishment inspection report (eir).